Phacoemulsification and 25 Gauge (25G) Vitrectomy Versus Phacoemulsification Only in Idiopathic Epiretinal Membranes

University of Turin

Status: Completed

Conditions: Epiretinal Membrane

Treatments: Procedure: phacoemulsification (cataract surgery); Procedure: 25-G vitrectomy and phacoemulsification

Study type: Interventional

Funder types: Other

Identifiers

NCT01771939

VTCMER2

Details and patient eligibility

About

The purpose of the study is to evaluate the difference in Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity, oct retinal thickness and microperimetry in 2 groups of 30 eyes each affected by idiopathic epiretinal membranes that underwent phacoemulsification and 25G pars-plana vitrectomy with internal limiting membrane (ILM) peeling (Group 1) versus phacoemulsification only (Group 2), with a follow-up length up to 5 years.

Full description

Idiopathic epiretinal membranes represent a common cause of visual loss in elderly population. Vitrectomy with membrane peeling is nowadays considered the gold standard in the management of such pathology, with very good results either at short-time or at long-time follow up. In case of mild visual impairment due to epiretinal membrane and associated cataract, it is reasonable to treat only the lens pathology (with phacoemulsification and intra-ocular lens (IOL) implantation). In case of symptoms or ophthalmoscopic finding worsening it is always possible to submit patients who only underwent cataract surgery to vitrectomy with membrane peeling. There are, by now, no comparative studies between these two different approaches in medical literature.

Enrollment: 60 patients

Sex: All

Ages: Under 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Idiopathic epiretinal membranes symptomatic

Exclusion criteria

• Absence of ocular symptoms, previous retinal interventions

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

idiopathic epiretinal membranes

Experimental group

Description:

Patients in first arm, with worse visual condition, treated with 25-G Vitrectomy and phacoemulsification (cataract intervention)

Treatment:

Procedure: 25-G vitrectomy and phacoemulsification

idiopathic epiretinal membrane

Active Comparator group

Description:

Patient in second arm, with better pre-operative condition, treated with phacoemulsification (cataract intervention) only

Treatment:

Procedure: phacoemulsification (cataract surgery)